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Human Growth Hormone Drugs

Human Growth Hormone Drugs

This report analyzes the worldwide markets for Human Growth Hormone Drugs in US$ Million. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World.  Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 28 companies including many key and niche players such as -

 Eli Lilly and Company
Ferring Holding SA
Genentech, Inc.
GeneScience Pharmaceuticals Co., Ltd.
Merck KgaA


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I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
II. EXECUTIVE SUMMARY
1. INDUSTRY OVERVIEW
Market Outlook
Evolution of Recombinant Human Growth Hormones (hGH)
Patent Expiry Paves Way for the Emergence of Biosimilars; Impact Remains Small
Strong Innovation Drive Takes Hold of the hGH Industry
Sizing the Market
Key Growth Drivers
High Prevalence of Growth Hormone Deficiency Disorders
Innovations Hold the Key to Market Growth
New Indications for hGH Replacement Therapy
Major Growth Restraining Factors
Complex Delivery System
High Cost of hGH Treatment
Difficulty in Securing Reimbursement
Biosimilars Threaten Revenue Growth Erosion
Limited Pharmacological Differences Exist Among Current Agents
2. MARKET TRENDS & ISSUES
Pediatric GHD Rules, while Adult GHD Remains Underserved
Table 1: Worldwide Recombinant Human Growth Hormone Market by Indication (2016E): Percentage Breakdown of Value Sales for Adult GHD, Turner Syndrome & Idiopathic Short Stature; Pediatric GHD; and Others (includes corresponding Graph/Chart)
Long-Acting hGH Drugs – a Potential Game Changer
Select Long-Acting hGH Products in Pipeline by Development Stage
Biosimilars Create Little Impact, Further Validation to Expand Indications and Growth
Table 2: Worldwide Biosimilar Demand by Product Category (2013): Percentage Breakdown of Value Sales for Epoetina, Granulocyte Colony-Stimulating Factors (G-CSFs), Interferons, Insulins, Low Molecular Weight Heparins (LMWH), Recombinant Human Growth Hormones (rhGHs), and Others (includes corresponding Graph/Chart)
Manufacturers Bet on Novel Drug Delivery Technologies
Phase IV Studies Necessitated for First Biosimilars
Needle-less Drug Delivery Systems to Wipe Out of Syringes
Drug Delivery Device Options for Marketed hGH Products
Growing Non-Prescription/Off-Label Usage – A Potential Health Hazard
Oral hGH Secretagogues – An Alternative to Controversial hGH Injections in Professional Sports
Risk of Cancer Necessitates Judicious Use of hGH in Children
Dose Titration – A Key to Achieve Enhanced Tolerability
Growth Concerns about Prolonged Usage of Growth Hormones
3. COMPETITIVE LANDSCAPE
hGH – A Highly Consolidated Market
Table 3: Leading Recombinant hGH Products in the Global Market (2015): Annual Sales in US$ Million for Genotropin, Humatrope, Norditropin, Nutropin and Saizen (includes corresponding Graph/Chart)
Overview of Select Leading Marketed hGH Products
Norditropin
Genotropin
Humatrope
Saizen
Omnitrope – the Somatropin Biosimilar
Somatropin Biopartners
Review of Select hGH Products in Pipeline
OPKO’s Lagova to be the Earliest of Long-Acting hGHs to Hit the Market
Somavaratan Advances Further in Clinical Trials
Somapacitan Moves Ahead in Development; Nears Commercial Launch
TransCon hGH – the Potential Blockbuster hGH Product in Waiting
4. HUMAN GROWTH HORMONE: AN OVERVIEW
5. RECENT INDUSTRY ACTIVITY
NHI Includes JCR Pharmaceuticals’s GROWJECT Liquid hGH Formulations in Reimbursement Listing
Ascendis Pharma Commences Phase III Trial on TransCon hGH
Teijin Inks License Deal with Versartis for Somavaratan
JCR Pharmaceuticals Obtains Japanese MHLW Approval for Growject® Liquid Formulations
Merck Dissolves Merck Serono and Merck Millipore Brands, Relaunches Merck Brand
EMD Serono and Aeterna Zentaris Finalize Promotional Services Deal for Saizen
Versartis Commences Phase II/III Studies for
in Japan
Ferring Pharmaceuticals Obtains FDA Clearance for Name Change of Growth Hormone
Hanmi Introduces Development-Stage Long Acting hGH
Novo Nordisk Obtains FDA Approval for Norditropin® FlexPro® Prefilled Pen
OPKO and Pfizer Ink Agreement for Development of OPKO's Long-acting hGH-CTP
Pfizer Announces Positive Results from Phase 3B Study on Genotropin for SGA in Children
6. FOCUS ON SELECT GLOBAL PLAYERS
Eli Lilly and Company (US)
Ferring Holding SA (Switzerland)
Genentech, Inc. (US)
GeneScience Pharmaceuticals Co., Ltd. (China)
Merck KgaA (Germany)
Novo Nordisk A/S (Denmark)
Pfizer, Inc. (US)
Sandoz International GmbH (Germany)
7. GLOBAL MARKET PERSPECTIVE
Table 4: World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 5: World Historic Review for Human Growth Hormone Drugs by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 6: World 14-Year Perspective for Human Growth Hormone Drugs by Geographic Region - Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)
III. MARKET
1. THE UNITED STATES
A. Market Analysis
Current & Future Analysis
US hGH Market – A Peek into GHD Prevalence and Cost of Treatment
Table 7: US Patient Volumes Receiving Growth Hormone Therapy by Indication (2016E): Breakdown of Number of Patients in Thousands for Adult GHD, Pediatric GHD and Other Indications (includes corresponding Graph/Chart)
Table 8: US hGH Market by Indication (2016E): Percentage Breakdown of Value Sales for Adult GHD, Idiopathic Short Stature, Pediatric GHD, Turner Syndrome and Others (includes corresponding Graph/Chart)
FDA Approvals Clear Way for Treating More Children
Major hGH Drugs Available in the US, and FDA Approved Indications
US FDA Promotes rhGH Development through Orphan Drug Designation
FDA Approval of First Biosimilar
Omnitrope Versus Genotropin – A US Perspective
FDA Issues First Draft of Guidelines for Biosimilar and Interchangeable Biologicals
FDA Regulations Governing hGH Products in the OTC Drugs Market
Alarming Increase in Sales of hGH Drugs for Anti-Ageing Therapy
Strategic Corporate Developments
Select Key Players
B. Market Analytics
Table 9: The US Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 10: The US Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
2. CANADA
Market Analysis
Table 11: Canadian Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 12: Canadian Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
3. JAPAN
A. Market Analysis
Current & Future Analysis
Market Overview
Table 13: Japanese Patient Volumes Receiving Growth Hormone Therapy by Indication (2016E): Breakdown of Number of Patients in Thousands for Adult GHD, Pediatric GHD and Other Indications (includes corresponding Graph/Chart)
Table 14: Japanese hGH Market by Indication (2016E): Percentage Breakdown of Value Sales for Pediatric GHD and Others (includes corresponding Graph/Chart)
Competition in the Japanese hGH Market
Table 15: Key Players in the Japanese hGH Market (2012, 2014 & 2016): Percentage Breakdown of Value Sales for Eli Lilly, JCR, Novo Nordisk, Pfizer and Others (includes corresponding Graph/Chart)
Timeline of Major Approvals for JCR Pharmaceutical’s hGH Product Growject
Japanese Biosimilar Regulatory Guidelines
Sandoz’ Omnitrope – the First Biosimilar hGH Launched in Japan
Strategic Corporate Developments
B. Market Analytics
Table 16: Japanese Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 17: Japanese Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
4. EUROPE
A. Market Analysis
Current & Future Analysis
Pediatric GHD – Leading Target Indication for hGH Products
Table 18: European Patient Volumes Receiving Growth Hormone Therapy by Indication (2016E): Breakdown of Number of Patients in Thousands for Adult GHD, Pediatric GHD and Other Indications (includes corresponding Graph/Chart)
Table 19: European hGH Market by Indication (2016E): Percentage Breakdown of Value Sales for Adult GHD, Pediatric GHD and Others (includes corresponding Graph/Chart)
European hGH Market Focuses on Product Differentiation to Revitalize Sales
Regulations Pertaining to Biosimilars in the EU
Table 20: Adoption Rates for hGH Biosimilar in Major Western Europe Markets: 2016 (includes corresponding Graph/Chart)
New Indications Could Drive Growth
B. Market Analytics
Table 21: European Recent Past, Current and Future Analysis for Human Growth Hormone Drugs by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 22: European Historic Review for Human Growth Hormone Drugs by Geographic Region - France, Germany, Italy, UK, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
Table 23: European 14-Year Perspective for Human Growth Hormone Drugs by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain, and Rest of Europe Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart)
4a. FRANCE
Market Analysis
Table 24: French Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 25: French Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
4b. GERMANY
A. Market Analysis
Current & Future Analysis
Strategic Corporate Development
Key Players
B. Market Analytics
Table 26: German Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 27: German Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
4c. ITALY
Market Analysis
Table 28: Italian Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 29: Italian Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
4d. THE UNITED KINGDOM
Market Analysis
Table 30: The UK Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 31: The UK Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
4e. SPAIN
Market Analysis
Table 32: Spanish Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 33: Spanish Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
4f. REST OF EUROPE
A. Market Analysis
Current & Future Analysis
Strategic Corporate Development
Select Key Players
B. Market Analytics
Table 34: Rest of Europe Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 35: Rest of Europe Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
5. ASIA-PACIFIC
A. Market Analysis
Current & Future Analysis
Biosimilar Regulations In Asian Countries
South Korea
China
India
Genescience Pharmaceuticals Co., Ltd. – A Leading Chinese Player
B. Market Analytics
Table 36: Asia-Pacific Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 37: Asia-Pacific Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
6. REST OF WORLD
Market Analysis
Table 38: Rest of World Recent Past, Current and Future Analysis for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
Table 39: Rest of World Historic Review for Human Growth Hormone Drugs Market Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart)
IV. COMPETITIVE LANDSCAPE Total Companies Profiled: 28 (including Divisions/Subsidiaries - 33)
The United States (10)
Canada (1)
Japan (2)
Europe (10)
- Germany (4)
- The United Kingdom (2)
- Rest of Europe (4)
Asia-Pacific (Excluding Japan) (9)
Middle East (1)

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